In Praise of Good Corporate Behavior: Medtronic

It's critically important that if this blog is to be about ethics at the interface between medicine and for-profit industry (drug or device), that I am equally attentive to good corporate behavior as to scandals. This can be challenging as we've seen numerous examples of egregious corporate behavior spun by creative PR so as to appear virtuous. But if it really seems that a company has seen the error if its ways, we should take note and be appropriately respectful.

So is Medtronic now in this august category?http://tcbmag.blogs.com/daily_developments/2011/08/medtronic-pays-yale-to-review-controversial-bone-product.htmlTwo things make me accept this account as indicative of genuine corporate responsibility. First, the person who sent me the link is a hard-headed critic of industry and has often seen through PR fluff in the past when I could have been fooled. Second, the person selected to do the study of Medtronic's products, Dr. Harlan Krumholz, has what I believe to be an unassailable position as an independent industry critic. If you want somebody to paper over your misdeeds, he would be a pretty pooor choice.

If we ever want to have a relationship between the medical profession and the industry that takes full advantage of the benefits of collaboration while avloiding the ethical cesspool of today's conflicts of interest, we need models of effective neutral turf where industry and professional folk can foregather to address the issues and see what sorts of new developments might be proposed, without the setting itself creating new conflicts of interest or dangers of one side controlling the discussion for its own ends. I am not sure that this Yale study will be a model applicable to other such settings, but it's certainly a welcome development if it is what it seems to be.

3 comments:

I would really like to believe this is a good faith effort on Medtronic's part, but I think we need to set up a mechanism by which companies can put money into a pot, and data, but they can't have any control over the study design, execution, or publication. And academic researchers need to be able to ask for more data. In this case, the control still lies with Medtronic and the data it chooses to disclose.

I was very kindly supplied with this comment by Dr. Harlan Krumholz who's mentioned in the original post--Howard Brody

I appreciate Shannon's concerns and skepticism - certainly they are understandable. Nevertheless, we have sought to design this model to provide as much distance and independence from the company as possible - and assurance to the public about the credibility of the effort. We have complete control. They have no control over an aspect of the evaluation or dissemination of the data. They provide the data and we set the rules for the evaluation, select the organizations to evaluate the data, select the steering committee, determine the terms for the release of the data to other investigators. We will be conducting a conference and taking input on the data dissemination process, but we will not serve as gatekeepers. Our choice not to perform the analysis ourselves but to find two other groups to do it should provide some additional credibility - and anyone who doubts their analysis can repeat it for themselves. No company has ever done this. My hope is to make it difficult for the companies to resist the public need for access to the data. Medtronic has shown what is possible - and it should become standard operating procedure.

I am very sorry, but a typo get inserted into Dr. Krumholz's statement as conveyed in the previous comment that I posted-- the corrected version follows:

I appreciate Shannon's concerns and skepticism - certainly they are understandable. Nevertheless, we have sought to design this model to provide as much distance and independence from the company as possible - and assurance to the public about the credibility of the effort. We have complete control. They have no control over any aspect of the evaluation or dissemination of the data. They provide the data and we set the rules for the evaluation, select the organizations to evaluate the data, select the steering committee, determine the terms for the release of the data to other investigators. We will be conducting a conference and taking input on the data dissemination process, but we will not serve as gatekeepers. Our choice not to perform the analysis ourselves but to find two other groups to do it should provide some additional credibility - and anyone who doubts their analysis can repeat it for themselves. No company has ever done this. My hope is to make it difficult for the companies to resist the public need for access to the data. Medtronic has shown what is possible - and it should become standard operating procedure.